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Site Specialist - Clinical Supplies Management

Facility:  Clinical Development and Medical
Location: 

Plainsboro, NJ, US

About the Department                                                                                                                                               

The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the Food & Drug Administration (FDA) to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient-centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We’re changing lives for a living. Are you ready to make a difference?

 

The Position

Takes ownership to deliver upon near-term North American Clinical Operations (NACO) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly complex cross-functional improvement/innovation projects for the department (subset) of NACO and/or as part of a global team and as aligned to a business case, goals and/or future aspirations. Contributes to a continually changing environment, supporting a future focused approach, leveraging competencies, tools and technology. Maintains responsibility for quality, performance, regulatory compliance and patient safety related to managing assigned clinical trial sites, trial product handling and document handling.

 

Relationships

Reports to a Manager (or above) within NACO. Manages mutually beneficial relationships with external partners such as vendors and investigative trial sites relevant to clinical supplies including trial product/study intervention, laboratory kits, trial specific and ancillary supplies. Manages relationships positively with multiple internal stakeholders relevant to the design and implementation of clinical trials improvement/innovation projects for NACO and Novo Nordisk (e.g., across NACO, CMR, International Operations (IO), HQ R&D, HQ Clinical Supplies, and Commercial). Provides excellent customer service and builds strong working relationships with vendors, investigative sites and internal cross-functional partners.

 

Essential Functions

  • Project Support
    • Act as a main source of support for NACO to ensure that quality and patient safety, rights and well-being, data integrity, scientific validity & compliance with relevant regulatory requirements at investigational sites are adhered to during receipt, storage and handling of clinical supplies across the trial lifecycle
    • Responsible for managing supply logistics including inventory management and procurement of trial specific/ancillary supplies
    • Contributes actively to Trial Core Team and other relevant teams
  • GxP Support
    • Assist in trial product/study intervention release process for NACO
    • Act as trial product/study intervention handling expert for Standard Operating Procedure (SOP) and GxP input
    • Support during FDA and internal audits
  • Functional Management
    • Responsible for vendor management serving as primary contact for day to day operational support, coordinating, escalating and helping resolve trial specific/ancillary/laboratory kits/trial product/study intervention related issues with external vendors
    • Manage and maintain tracking, approval and collection of drug/study intervention destruction documentation during trial life cycle
    • Manage and maintain tracking, approval and collection of all study specific devices across all of NACO
    • Work with various stakeholders including but not limited to Scientific Alliance Management and HQ to support global and NACO initiatives related to trial product/study intervention handling, ancillary supply handling and vendor management
    • Source, procure, and manage logistics and inventory of ancillary supplies for clinical trials. Role requires facilitating purchase orders, placing orders, logistics and communicating supply status updates to relevant stakeholders
  • General Support
    • Identify clinical supplies handling communication and/or process gaps and initiate solutions. Work with various stakeholders to implement and assist in identifying the root causes of clinical supply handling process related issues affecting compliance and quality. This includes but not limited to oversight of temperature tracking and monitoring systems (HOT system) and various trial product integration systems
    • Demonstrates technical expertise within responsibility areas, staying up-to-date of new practices and building knowledge of emerging trends and advances within area
  • Regional Management & Staff Development
    • Support the identification of training needs within function and the development of training materials to meet those needs including but not limited to New Hire Training, NACO core competency training and investigational site training

 

Physical Requirements

10-20% overnight travel required; May be required to work company holidays and weekends.

 

Qualifications

 

  • A Bachelor’s degree is required (science-related discipline preferred)

  • A minimum of 5 years of clinical trial experience within a pharmaceutical, biotechnology, CRO and/or healthcare setting or applicable industry experience

  • Clinical trial supply management experience preferred including experience in handling of clinical supplies as related to study intervention and ancillary supplies handling

  • Demonstrated understanding of medical terminology and ICH-GCP principles and the application of those principles to trial planning and conduct of clinical trials

  • Demonstrated collaborative and stakeholder management skills

  • Experience working in a technical and system driven environment

  • Demonstrated understanding of trial product/system intervention handling procedures

  • Experience working with IRT solutions and inventory management systems preferred

  • Demonstrated computer skills (MS Office, MS Project, MS PowerPoint)

  • Excellent communications skills (verbal, written, presentation) in English

 

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

 

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

 

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.